Insulin Glulisine, Diabetes Mellitus Type 1

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin glulisine

• Registration Number: NCT00397553
• Lead Sponsor: Sanofi

Brief Summary

To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-11-08
• Study First Submitted QC: 2006-11-08
• Study First Posted: 2006-11-09
• Primary Completion: 2007-12
• Status Verified: 2009-05
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Diabetes mellitus, Type 1
• HbA1c 6.5-11.0%
• BMI <35 kg/m²

Exclusion Criteria

• Diabetes mellitus, Type 2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin Glulisine	Insulin glulisine	-

Primary Outcome Measures

Name	Time	Method
HbA1c	52 weeks

Secondary Outcome Measures

Name	Time	Method
HbA1c	26 weeks
Fasting Blood Glucose	52 weeks
Post-prandial glycemia (2 hour after breakfast)	52 weeks

Trial Locations

Locations (1)

Sanofi-Aventis; 🇷🇺 Moscow, Russian Federation